Predicting the future is no easy feat without the help of a time machine. Often, that’s a good thing. But, sometimes, it’s not so good – one example being with restricted substances. If these substances are included in products, the results can be expensive fines, loss of market share and stock value, and (worst of all) damage to brand reputation. Many companies are struggling even to avoid use of substances that are already regulated. But, with new substances being added to restricted lists all the time, that may not be enough. How do we avoid using substances that are likely to become unusable during the lifetime of the product?
This week, I presented in a collaborative webinar with Cook Medical’s David Chadwick, Director of Regulatory Affairs, covering the best practise when applying materials data and predicate device information in healthcare. The healthcare industry faces a colossal task when choosing materials for use in new or existing medical devices. For those unfamiliar with the medical industry, the number of factors which need to be carefully considered when selecting a material for use in the human body can seem overwhelming; engineering properties, biocompatibility, effect of sterilization treatments, material-drug interactions, regulatory approval processes such as FDA approval and CE Marking, just to name a few. Continue reading
The world of materials never stands still. New technological challenges constantly drive the need to explore new materials that offer properties that no existing material can deliver. It is vital to maintain a single, up-to-date source of materials property data, to keep abreast of all these new developments. How else can you ensure that your designers and engineers have the data they need for materials selection, product design, simulation, qualification, and more?
If two heads are better than one, imagine the benefits of two communities coming together to share each other’s views on materials and processes to make the best designed, best engineered products. That’s the premise behind a new educational project at Granta Design.
If we can inspire designers and engage engineers to learn about each other’s vital role in product development, and enable them to communicate in the common language of materials, we can arrive at a whole that is much greater than the sum of the parts. Two views, one vision. The new CES EduPack ‘Products, Materials and Processes’ Database offers university educators and their students two views of materials information, the Designer’s View and the Engineer’s View, so both can learn how to create successful products that are functional and aesthetically pleasing.
Consumer product development is distinguished from other manufacturing sectors by high turnaround, with many products having a typical lifespan of no more than two to five years. Whether household appliances, electronic devices, or even cars, the market has a constant appetite for new products and its attention is fickle. Tastes evolve—a product that was the epitome of good design five years ago may now look dated. Even the most cutting-edge devices may only secure demand for so long before market share is lost to competitors or newer technology. Manufacturers have a limited horizon in which to capitalize on the success of their new products and generate profit, and they need to get it right. But how?
Completely new materials in the field of implantable devices are a rare occurrence. This is because of the heavy regulatory burden placed on implantable medical devices to ensure that they are safe and effective for use in the specified application. There has to be a very good reason to invest in the cost of qualifying a new material over the ones that have a long standing history in the field. However, one group of materials that seem likely to cross that boundary and have been gaining increasing attention in recent years are bioabsorbable magnesium alloys. But what are these alloys and why are they gaining such attention? Continue reading
Discovered in 1877 and patented in 1933, PMMA, or acrylic, is often used as a lighter, more shatter-resistant alternative to glass. It is easy to process and make, resulting in a low cost versatile material used for everything from windows in aquariums, to protecting the audience from stray pucks in ice hockey rinks, and even in shoes.
What is interesting about PMMA, though, is its biocompatibility. Despite being formed by polymerizing Methyl Methacrylate, an irritant, and possibly a carcinogen, PMMA is extremely biocompatible, resistant to long exposure to temperatures, chemistry and cell action of human tissue. Continue reading